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NCT04432896
Systemic Nickel Allergy Syndrome: Intervention Study for the Assessment of the Dietary Indications
NA trial testing Dietary protocol in Nickel Sensitivity in 53 participants. Completed in 1 December 2020.
1 November 2020
Quick facts
| Lead sponsor | University of Pavia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 1 December 2018 |
| Primary completion | 1 November 2020 |
| Estimated completion | 1 December 2020 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Dietary protocol
Conditions studied
- Nickel Sensitivity — all drugs for Nickel Sensitivity →
- Allergy — all drugs for Allergy →
- Nickel; Eczema — all drugs for Nickel; Eczema →
- Women — all drugs for Women →
Sponsor
University of Pavia
Who can join
18 and older, female only, with Nickel Sensitivity or Allergy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Nickel is a silvery metal widely used in nature and contained in many foods. Exposure to nickel is responsible for two different types of adverse reactions: Allergic Contact Dermatitis (DAC) and Systemic Nickel Allergy Syndrome (SNAS). The latter is characterized by the presence of extra-cutaneous manifestations, in addition to the skin lesions of the DAC, related to the introduction of nickel-containing foods. Therefore, a nutritional intervention is essential to reduce the symptoms of SNAS. Currently in the literature there are no nutritional guidelines on the treatment and management of patients suffering from SNAS and often the indications provided to patients involve the exclusion of groups of foods for prolonged periods, with the consequent risk of developing nutritional deficiencies and malnutrition. Objectives: to evaluate the efficacy of dietary indications, developed on the most recent scientific evidence, useful for the management of the symptoms associated with adverse reactions to Nickel. Provide practical indications to specialist staff in multidisciplinary patient management and make the patient aware of his problem and help him understand how to manage it independently. Target population: subjects over the age of 18, female, belonging to the U.O. Occupational Medicine Allergology Section at ICS Maugeri of Pavia, with previous diagnosis of Nickel allergy (patch test) and with the presence of gastrointestinal symptoms related to allergy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04432896
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Nickel Sensitivity
Currently open trials in the same condition.
- NCT06529913 — Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases · NA · recruiting
Other University of Pavia trials
Trials by the same sponsor.
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- NCT07199712 — Ozone Therapy for Oral Mucositis in Patients Receiving Head and Neck Cancer Radio- and Chemotherapy · NA · completed
- NCT07088653 — Comparison of 0.12% Chlorhexidine and MicroRepair ABX Mouthwash in Gingivitis Management · NA · completed
- NCT07140146 — Trehalose vs Glycine Air-Polishing in Peri-Implant Mucositis Treatment · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04432896 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Pavia
- Last refreshed: 15 June 2021
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